Trial Outcomes & Findings for Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial (NCT NCT00315120)

NCT ID: NCT00315120

Last Updated: 2016-07-06

Results Overview

Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 455 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-07-06

Participant Flow

A total of 455 participants were recruited from the Dallas-Fort Worth, Texas metroplex from August 2006 to September 2010 through newspaper advertisements, community agencies, and medical clinics, excluding OMT specialty clinics.

Participants were randomized after their study eligibility was confirmed by both telephonic and clinical screening examinations.

Participant milestones

Measure	OMT + UST Active osteopathic manipulation and active ultrasound physical therapy	Sham OMT + UST Sham osteopathic manipulation and active ultrasound physical therapy	OMT + Sham UST Active osteopathic manipulation and sham ultrasound physical therapy	Sham OMT + Sham UST Sham osteopathic manipulation and sham ultrasound physical therapy
Overall Study STARTED	115	118	115	107
Overall Study COMPLETED	115	118	115	107
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial

Baseline characteristics by cohort

Measure	OMT + UST n=115 Participants Active osteopathic manipulation and active ultrasound physical therapy	Sham OMT + UST n=118 Participants Sham osteopathic manipulation and active ultrasound physical therapy	OMT + Sham UST n=115 Participants Active osteopathic manipulation and sham ultrasound physical therapy	Sham OMT + Sham UST n=107 Participants Sham osteopathic manipulation and sham ultrasound physical therapy	Total n=455 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=5 Participants	117 Participants n=7 Participants	112 Participants n=5 Participants	105 Participants n=4 Participants	445 Participants n=21 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Age, Continuous	40.50 years STANDARD_DEVIATION 13.05 • n=5 Participants	39.19 years STANDARD_DEVIATION 11.90 • n=7 Participants	41.97 years STANDARD_DEVIATION 12.58 • n=5 Participants	41.38 years STANDARD_DEVIATION 12.99 • n=4 Participants	40.74 years STANDARD_DEVIATION 12.63 • n=21 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	68 Participants n=7 Participants	78 Participants n=5 Participants	72 Participants n=4 Participants	284 Participants n=21 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	50 Participants n=7 Participants	37 Participants n=5 Participants	35 Participants n=4 Participants	171 Participants n=21 Participants
Region of Enrollment United States	115 participants n=5 Participants	118 participants n=7 Participants	115 participants n=5 Participants	107 participants n=4 Participants	455 participants n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks

Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)	40 participants	20 participants

PRIMARY outcome

Timeframe: 12 weeks

Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)	32 participants	28 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Week 4 Data

Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)	4 RMDQ Scale Interval 2.0 to 8.0	5 RMDQ Scale Interval 2.0 to 9.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Week 8 Data

Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)	3 RMDQ Scale Interval 1.0 to 7.0	3 RMDQ Scale Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Week 12 Data

Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)	2 RMDQ Scale Interval 1.0 to 6.0	3 RMDQ Scale Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Week 4 Data

Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)	4 RMDQ Scale Interval 2.0 to 9.0	5 RMDQ Scale Interval 2.0 to 9.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Week 8 Data

Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)	3 RMDQ Scale Interval 1.0 to 8.0	4 RMDQ Scale Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Week 12 Data

Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)	3 RMDQ Scale Interval 1.0 to 7.0	3 RMDQ Scale Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: 4 weeks

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)	71 SF-36 General Health Score Interval 55.0 to 82.0	72 SF-36 General Health Score Interval 52.0 to 86.0

SECONDARY outcome

Timeframe: 8 weeks

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)	72 SF-36 General Health Score Interval 57.0 to 85.0	72 SF-36 General Health Score Interval 52.0 to 85.0

SECONDARY outcome

Timeframe: 12 weeks

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Outcome measures

Measure	Active OMT n=230 Participants Active osteopathic manipulation	Sham OMT n=225 Participants Sham osteopathic manipulation
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)	72 SF-36 General Health Score Interval 52.0 to 87.0	72 SF-36 General Health Score Interval 57.0 to 87.0

SECONDARY outcome

Timeframe: 4 Weeks

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)	72 SF-36 General Health Score Interval 54.0 to 87.0	72 SF-36 General Health Score Interval 52.0 to 82.0

SECONDARY outcome

Timeframe: 8 Weeks

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)	72 SF-36 General Health Score Interval 54.0 to 85.0	72 SF-36 General Health Score Interval 57.0 to 85.0

SECONDARY outcome

Timeframe: 12 Weeks

The general health scale ranges from 0 to 100, with higher scores representing better general health.

Outcome measures

Measure	Active OMT n=233 Participants Active osteopathic manipulation	Sham OMT n=222 Participants Sham osteopathic manipulation
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)	72 SF-36 General Health Score Interval 52.0 to 87.0	74 SF-36 General Health Score Interval 54.0 to 87.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Lost 1 or more days of work in past 4 weeks because of low back pain.

Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

Outcome measures

Measure	Active OMT n=107 Participants Active osteopathic manipulation	Sham OMT n=100 Participants Sham osteopathic manipulation
Work Disability (OMT and Sham OMT - Week 4)	11 Participants who reported lost work days Interval 4.0 to 17.0	14 Participants who reported lost work days Interval 7.0 to 21.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Lost 1 or more days of work in past 4 weeks because of low back pain.

Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

Outcome measures

Measure	Active OMT n=108 Participants Active osteopathic manipulation	Sham OMT n=103 Participants Sham osteopathic manipulation
Work Disability (OMT and Sham OMT - Week 8)	7 Participants who reported lost work days Interval 2.0 to 12.0	20 Participants who reported lost work days Interval 12.0 to 28.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Lost 1 or more days of work in past 4 weeks because of low back pain.

Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

Outcome measures

Measure	Active OMT n=108 Participants Active osteopathic manipulation	Sham OMT n=103 Participants Sham osteopathic manipulation
Work Disability (OMT and Sham OMT - Week 12)	12 Participants who reported lost work days Interval 5.0 to 18.0	8 Participants who reported lost work days Interval 3.0 to 13.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Lost 1 or more days of work in past 4 weeks because of low back pain.

Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

Outcome measures

Measure	Active OMT n=110 Participants Active osteopathic manipulation	Sham OMT n=97 Participants Sham osteopathic manipulation
Work Disability (UST and Sham UST - Week 4)	18 Participants who reported lost work days Interval 10.0 to 25.0	7 Participants who reported lost work days Interval 2.0 to 12.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Lost 1 or more days of work in past 4 weeks because of low back pain.

Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

Outcome measures

Measure	Active OMT n=112 Participants Active osteopathic manipulation	Sham OMT n=99 Participants Sham osteopathic manipulation
Work Disability (UST and Sham UST - Week 8)	19 Participants who reported lost work days Interval 11.0 to 27.0	8 Participants who reported lost work days Interval 3.0 to 14.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Lost 1 or more days of work in past 4 weeks because of low back pain.

Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.

Outcome measures

Measure	Active OMT n=112 Participants Active osteopathic manipulation	Sham OMT n=99 Participants Sham osteopathic manipulation
Work Disability (UST and Sham UST - Week 12)	14 Participants who reported lost work days Interval 7.0 to 21.0	6 Participants who reported lost work days Interval 1.0 to 11.0

SECONDARY outcome

Timeframe: 4 weeks

Subjects who reported being very satisfied with back care

Outcome measures

Measure	Active OMT n=208 Participants Active osteopathic manipulation	Sham OMT n=208 Participants Sham osteopathic manipulation
Satisfaction With Back Care (OMT and Sham OMT - Week 4)	109 participants Interval 96.0 to 123.0	71 participants Interval 58.0 to 85.0

SECONDARY outcome

Timeframe: 8 weeks

Subjects who reported being very satisfied with back care

Outcome measures

Measure	Active OMT n=213 Participants Active osteopathic manipulation	Sham OMT n=213 Participants Sham osteopathic manipulation
Satisfaction With Back Care (OMT and Sham OMT - Week 8)	129 participants Interval 115.0 to 143.0	84 participants Interval 70.0 to 98.0

SECONDARY outcome

Timeframe: 12 weeks

Subjects who reported being very satisfied with back care

Outcome measures

Measure	Active OMT n=216 Participants Active osteopathic manipulation	Sham OMT n=213 Participants Sham osteopathic manipulation
Satisfaction With Back Care (OMT and Sham OMT - Week 12)	143 participants Interval 130.0 to 158.0	92 participants Interval 77.0 to 107.0

SECONDARY outcome

Timeframe: 4 weeks

Subjects who reported being very satisfied with back care

Outcome measures

Measure	Active OMT n=210 Participants Active osteopathic manipulation	Sham OMT n=206 Participants Sham osteopathic manipulation
Satisfaction With Back Care (UST and Sham UST - Week 4)	87 participants Interval 74.0 to 101.0	93 participants Interval 78.0 to 107.0

SECONDARY outcome

Timeframe: 8 weeks

Subjects who reported being very satisfied with back care

Outcome measures

Measure	Active OMT n=217 Participants Active osteopathic manipulation	Sham OMT n=209 Participants Sham osteopathic manipulation
Satisfaction With Back Care (UST and Sham UST - Week 8)	107 participants Interval 93.0 to 122.0	106 participants Interval 92.0 to 121.0

SECONDARY outcome

Timeframe: 12 weeks

Subjects who reported being very satisfied with back care

Outcome measures

Measure	Active OMT n=219 Participants Active osteopathic manipulation	Sham OMT n=210 Participants Sham osteopathic manipulation
Satisfaction With Back Care (UST and Sham UST - Week 12)	120 participants Interval 105.0 to 134.0	115 participants Interval 101.0 to 130.0

Adverse Events

OMT + UST

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham OMT + UST

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

OMT + Sham UST

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham OMT + Sham UST

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	OMT + UST n=115 participants at risk Active osteopathic manipulation and active ultrasound therapy	Sham OMT + UST n=118 participants at risk Sham osteopathic manipulation and active ultrasound therapy	OMT + Sham UST n=115 participants at risk Active osteopathic manipulation and sham ultrasound therapy	Sham OMT + Sham UST n=107 participants at risk Sham osteopathic manipulation and sham ultrasound therapy
General disorders Any serious adverse event according to Food and Drug Administration definition	0.87% 1/115 • Number of events 1 • 12 weeks	1.7% 2/115 • Number of events 2 • 12 weeks	4.3% 5/115 • Number of events 5 • 12 weeks	0.93% 1/107 • Number of events 1 • 12 weeks

Other adverse events

Measure	OMT + UST n=115 participants at risk Active osteopathic manipulation and active ultrasound therapy	Sham OMT + UST n=118 participants at risk Sham osteopathic manipulation and active ultrasound therapy	OMT + Sham UST n=115 participants at risk Active osteopathic manipulation and sham ultrasound therapy	Sham OMT + Sham UST n=107 participants at risk Sham osteopathic manipulation and sham ultrasound therapy
General disorders Any other adverse event	5.2% 6/115 • Number of events 6 • 12 weeks	4.2% 5/118 • Number of events 5 • 12 weeks	3.5% 4/115 • Number of events 4 • 12 weeks	2.8% 3/107 • Number of events 3 • 12 weeks

Additional Information

John C. Licciardone, DO, MS, MBA

University of North Texas Health Science Center-The Osteopathic Research Center

Phone: 817-735-2028

Email: john.licciardone@unthsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place